Intracochlear Triamcinolone acetonide in sudden sensorineural hearing loss patients - a prospective observer blinded randomized study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Trial duration

11 Dec 2024 → ongoing

Decision date (initial)

2024-12-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513145-36-00

EudraCT number

2020-005300-19

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Evaluation of the effect of intracochlear application of triamcinolone acetonide on hearing function measured by the pure tone audiometry, in the treatment of patients with persistent sudden sensorineural hearing loss (SSHL) after unsuccessful conservative therapy.

Secondary objectives 4

1. Evaluation of the effect of triamcinolone acetonide on the speech intelligibility.
2. Evaluation of the effect of triamcinolone acetonide on the intensity of tinnitus, quality speech intelligibility and the perception of the own health condition.
3. Investigation of the protein content in the perilymph
4. Investigation of the concentration of triamcinolone acetonide (if applicable) and proteins depending on the results of the perilymph proteomics

Conditions and MedDRA coding

Sudden sensori neural hearing loss

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients between 18 and 80 years within 21 days beginning from the onset of SSHL
2. Failed recovery after conservative treatment (systemic and intratympanic steroids) due to persisting SSHL
3. Patients with SSHL with a mean hearing threshold shift of ≥30dB in three adjacent frequencies (0.125, 0.25, 0.5, 1, 2, 4, 8 kHz).
4. Patients with an absolute mean hearing threshold of ≥70dB in the frequencies 0.5, 1, 2 and 4 kHz.
5. Patients who signed the informed consent

Exclusion criteria 11

1. Missing informed consent
2. Patients under permanent corticosteroid therapy
3. Patients with hearing loss due to a (suspected) rupture of the round window membrane according to their history
4. Patients with an intraoperatively detected leak of the round window membrane
5. Repetitive SSHL within the last 12 months on the same side
6. Other ear diseases systemic or otologic (e.g. middle ear diseases, vestibular schwannoma, fluctuating hearing loss, Menière ́s Disease)
7. Central nervous disorders
8. Certain systemic diseases
9. Ongoing treatment with aminoglycosides (e.g. gentamicin), erythromycin, tetracycline, chemotherapeutic agents (e.g. cisplatin, 5- fluorouracil, bleomycin), high-dose aspirin (6 to 8 g/day), phosphodiesterase 5 inhibitors (e.g. sildenafil), antimalarial medications (e. g. quinine and chloroquine), loop diuretics (e.g. furosemide, torasemid, acetazolamide), immunosuppressive drugs
10. Preexisting conductive hearing loss on the affected side (mean air- bone gap >10dB in the frequencies 0.5, 1, 2 and 4 kHz)
11. Pregnancy or nursing

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean hearing threshold shift on day 30 postoperatively in three sequential frequencies most affected by SSHL.

Secondary endpoints 4

1. Freiburger monosyllable speech intelligibility test and the oldenburg sentence test on day 30 postoperatively
2. Intensity of tinnitus, quality of speech intelligibility and the perception of the own health condition on day 30 postoperatively
3. Proteomics of the perilymph
4. Concentration of triamcinolone acetonide (if applicable) and proteins depending on the results of the perilymph proteomics

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Ear, Nose and Throat Disease

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Ear, Nose and Throat Disease

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications